胶囊内窥镜临床应用及临床评价关注要点分析  

Analysis of the key points of clinical application and clinical evaluation of capsule endoscope

作　　者：张译丹 卢敏琪 李妮娅 程玮璐 刘斌 Zhang Yidan;Lu Minqi;Li Niya;Cheng Weilu;Liu Bin(Greater Bay Area Center,Medical Device Evaluation and Inspection,National Medical Products Administration,Shenzhen 518045,China;Center for Medical Device Evaltation,National Medical Products Administration,Beijing,100076,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评检查大湾区分中心,深圳518045 [2]国家药品监督管理局医疗器械技术审评中心,北京100076

出　　处：《中国医学装备》2024年第11期151-156,共6页China Medical Equipment

基　　金：广东省重点领域研发计划(2022B0303020003)。

摘　　要：通过综述小肠、结肠、胃部和食管胶囊内窥镜等不同胶囊内窥镜临床使用情况,梳理不同疾病患者胶囊内窥镜临床应用相关评价指标,结合境内外已上市胶囊内窥镜产品审评过程,分析我国胶囊内窥镜产品上市需通过临床试验路径进行临床评价的关注要点,其临床评价关注内容包括主要评价指标、次要评价指标和安全性评价指标,主要评价指标可考虑病变诊断结果一致率和图像质量优良率;胶囊内窥镜产品临床试验入选标准为拟使用该产品的人群,排除标准需考量不适用于该类产品的情形及不适用于入组的情形。By summarizing the clinical use of different capsule endoscopes in small intestine,colon,stomach and esophagus,the relevant evaluation indicators of the clinical application of capsule endoscopes for patients with different diseases were sorted out.Combined with the review process of capsule endoscopes that have been marketed at home and abroad,the key points of clinical evaluation of capsule endoscopes products in China that need to be marketed through clinical trials were considered.The clinical evaluation focuses included main evaluation index,secondary evaluation index and safety evaluation index,and the main evaluation index could consider the consistency rate of lesion diagnosis results and the excellent rate of image quality.The inclusion criteria for clinical trials of capsule endoscopy products were the population who intended to use the product,and the exclusion criteria need to consider the circumstances that were not applicable to such products and the circumstances that were not applicable to enrollment.

关 键 词：医疗器械 胶囊内窥镜 临床应用 临床评价 关注要点 

分 类 号：R197.39[医药卫生—卫生事业管理]